Bibliographical details of references provided in the subject specification are listed at the end of the specification.
Reference to any prior art in this specification is not, and should not be taken as, an acknowledgement or any form of suggestion that this prior art forms part of the common general knowledge in any country.
The need for rapid and reliable screening methods for detecting multiple analytes in a single assay is vital not only in the fields of clinical diagnosis, but also for use in screening, for example, for environmental toxins and drug screening.
One such area which is desperately in need of improved screening methods and reagents is in the field of infectious diseases. For example, a conservative estimate of the world use of diagnostic tests for sexually transmitted diseases, such as Human Papilloma Virus (HPV), is approximately 20,000,000 tests per year.
Many of the existing tests for screening for the causes of infectious diseases are time consuming, labor intensive, expensive, often specific for only one specific pathogen and/or cannot differentiate between different strains of pathogens.
HPV is the main causative pathogen for cervical cancer. However, the HPV taxon comprises many “strains” of the pathogen, only some of which are associated with the development of cervical cancer and other carcinomas. Accordingly, the strains of HPV are typically classified as either “high risk” strains, including the 13 strains which account for roughly 98% of cervical cases, or “low risk” strains which are not typically associated with the development of cervical cancer.
Currently, cervical cancer is detected by a Pap smear. In this technique, cells are collected from the cervix by scraping or washing. These cells are then placed on a glass microscope slide to produce the “smear”. A pathologist then examines the slide, looking for aberrant cells. The Pap smear, however, is a somewhat unsatisfactory assay for unequivocally determining cervical cancer risk, as the technique has a false negative rate of approximately 20% and the technique cannot distinguish “high risk” and “low risk” taxon.
Many of the reagents and/or methods for detection of HPV suffer from high associated costs and/or consume significant amounts of time to complete. More rapid and/or simplified analyses having lower overall costs and easier application are needed. The present invention is directed to these and other important ends.